Tresiba
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
21-02-2022
Produktets egenskaber
(SPC)
21-02-2022
Offentlige vurderingsrapport
(PAR)
20-03-2015
Aktiv bestanddel:
insulin degludec
Tilgængelig fra:
Novo Nordisk A/S
ATC-kode:
A10AE06
INN (International Name):
insulin degludec
Terapeutisk gruppe:
Drugs used in diabetes
Terapeutisk område:
Diabetes Mellitus
Terapeutiske indikationer:
Treatment of diabetes mellitus in adults.
Produkt oversigt:
Revision: 16
Autorisation status:
Authorised
Autorisation dato:
2013-01-20
Indlægsseddel
45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRESIBA 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
insulin degludec
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tresiba is and what it is used for
2.
What you need to know before you use Tresiba
3.
How to use Tresiba
4.
Possible side effects
5.
How to store Tresiba
6.
Contents of the pack and other information
1.
WHAT TRESIBA IS AND WHAT IT IS USED FOR
Tresiba is a long-acting basal insulin called insulin degludec. It is
used to treat diabetes mellitus in
adults, adolescents and children aged 1 year and above. Tresiba helps
your body reduce your blood
sugar level. It is used for once-daily dosing. On occasions when you
cannot follow your regular dosing
schedule, you can change the time of dosing because Tresiba has a long
blood sugar-lowering effect
(see section 3 for ‘Flexibility in dosing time’). Tresiba can be
used with meal-related rapid-acting
insulin products. In type 2 diabetes mellitus, Tresiba may be used in
combination with tablets for
diabetes or with injectable antidiabetic medicines, other than
insulin.
In type 1 diabetes mellitus, Tresiba must always be used in
combination with meal-related rapid-acting
insulin medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRESIBA
DO NOT USE TRESIBA
•
if you are allergic to insulin degludec or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tresiba 100 units/mL solution for injection in pre-filled pen
Tresiba 200 units/mL solution for injection in pre-filled pen
Tresiba 100 units/mL solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tresiba 100 units/mL solution for injection in pre-filled pen
One pre-filled pen contains 300 units of insulin degludec in 3 mL
solution.
1 mL solution contains 100 units insulin degludec* (equivalent to 3.66
mg insulin degludec).
Tresiba 200 units/mL solution for injection in pre-filled pen
One pre-filled pen contains 600 units of insulin degludec in 3 mL
solution.
1 mL solution contains 200 units insulin degludec* (equivalent to 7.32
mg insulin degludec).
Tresiba 100 units/mL solution for injection in cartridge
One cartridge contains 300 units of insulin degludec in 3 mL solution.
1 mL solution contains 100 units insulin degludec* (equivalent to 3.66
mg insulin degludec).
*Produced in
_Saccharomyces cerevisiae_
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tresiba 100 units/mL solution for injection in pre-filled pen
Solution for injection (FlexTouch).
Tresiba 200 units/mL solution for injection in pre-filled pen
Solution for injection (FlexTouch).
Tresiba 100 units/mL solution for injection in cartridge
Solution for injection (Penfill).
Clear, colourless, neutral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
from the age of 1 year.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product is a basal insulin for once-daily subcutaneous
administration at any time of the
day, preferably at the same time every day.
The potency of insulin analogues, including insulin degludec, is
expressed in units. One (1) unit of
insulin degludec corresponds to 1 international unit of human insulin,
1 unit of insulin glargine
(100 units/mL), or 1 unit of insulin detemir.
In pa
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